Value Pharma

Description

Aspirin, chemically known as Acetylsalicylic Acid, is presented as a white, crystalline powder. The formulation includes several inactive ingredients, specifically corn starch, hypromellose, microcrystalline cellulose, polyethylene glycol, stearic acid, and titanium dioxide.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains as recommended by a healthcare professional. Due to its delayed release action, this product is not suitable for the fast relief of headaches or symptoms requiring immediate alleviation.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this product.

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper administration and absorption.

For adults and children aged 12 years and older, the recommended dosage is 4 to 8 tablets every 4 hours. The total daily dosage should not exceed 48 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

There are no specific contraindications listed for this product. However, in the event of an overdose, it is imperative to seek medical assistance and contact a Poison Control Center immediately.

Warnings and Precautions

Patients with a history of allergic reactions to any pain relievers or fever reducers should not use this product. The potential for cross-reactivity necessitates caution in individuals with such a history.

Special attention is required for children and teenagers who are recovering from Chicken Pox or exhibiting flu-like symptoms, as the use of this product in these populations is contraindicated.

Healthcare professionals should be vigilant for any changes in behavior accompanied by nausea and vomiting during the use of this product. These symptoms may indicate the onset of Reye's Syndrome, a rare but serious condition that requires immediate medical consultation.

In the event of an overdose, it is imperative to seek medical assistance without delay. Contacting a Poison Control Center is also recommended to ensure appropriate management of the situation.

Side Effects

Patients should be aware of the potential for serious adverse reactions associated with the use of this product. It is contraindicated in individuals who have a history of allergic reactions to any other pain relievers or fever reducers. Additionally, children or teenagers recovering from Chicken Pox or flu-like symptoms should not use this product due to the risk of serious complications.

A notable warning includes the possibility of Reye's Syndrome, a rare but serious illness. Patients should consult a doctor if they experience changes in behavior accompanied by nausea and vomiting while using this product, as these symptoms may indicate the onset of this condition.

It is essential for patients to be informed of these risks to ensure safe and effective use of the product.

Drug Interactions

There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. As such, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Value Pharma (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients recovering from Chicken Pox or flu-like symptoms should not use this product. In cases where changes in behavior occur alongside nausea and vomiting, it is important to consult a doctor, as these symptoms may indicate Reye's Syndrome, a rare but serious condition.

For dosing, adults and children aged 12 years and older may take 4 to 8 tablets every 4 hours, with a maximum of 48 tablets in 24 hours unless otherwise directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is advised prior to use.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The use of this medication is contraindicated in pregnancy due to the potential risk to the fetus. Evidence indicates that exposure to this medication during pregnancy may pose risks, and therefore, it is essential for healthcare providers to advise pregnant patients against its use. Women of childbearing potential should be informed of these risks and the importance of effective contraception during treatment.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient and to determine the most appropriate interventions.

Overall, vigilance and prompt action are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance in the event of an overdose. It is crucial for patients to contact a Poison Control Center without delay if they suspect they have taken more than the recommended dose. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, maintaining a range of 20°C to 25°C (68°F to 77°F).

To ensure the integrity of the product, it must be protected from light and the container should remain tightly closed when not in use. Additionally, it is important to discard the product after opening to maintain safety and efficacy.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to seek immediate medical assistance and contact a Poison Control Center in the event of an overdose. Additionally, if patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor, as these symptoms may indicate Reye's Syndrome, a rare but serious condition.

Drug Information (PDF)

This file contains official product information for Value Pharma, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)